BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇲🇾 Malaysia

    Powder Free Blue Nitrile Examination Glove

    K Number: K153732 · Decision Jul 29, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    2
    Review Days
    214

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    Basic Information

    Device Name
    Powder Free Blue Nitrile Examination Glove
    K Number
    K153732
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Qube Medical Product Sdn Bhd
    Date Received
    December 28, 2015
    Decision Date
    July 29, 2016
    Product Code
    LZA
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LZA Polymer Patient Examination Glove

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    Other Clearances by Qube Medical Product Sdn Bhd

    K Number Device Name
    K123537 POWDER FREE LATEX EXAMINATION GLOVES